4 часа назад
Director, Global Clinical Development (Rare Diseases)
209 599 - 313 375$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Director, Global Clinical Development (Rare Diseases): Designing and overseeing global clinical research programs and protocols for rare disease, inherited metabolic disease, and specialty medicine products with an accent on clinical safety, efficacy, regulatory strategy, and value assessment. Focus on interpreting Phase I-IV investigations, supporting regulatory filings, managing CRO relationships, and guiding product life cycle development.
Location: Remote within the United States, or Princeton, NJ or Rockville, MD offices
Salary: $209,599–$313,375 annually, plus incentive opportunity
Company
develops pharmaceutical and healthcare products, including therapies for rare diseases, inherited metabolic diseases, and specialty medicine.
What you will do
- Design and oversee global clinical research programs and protocols under good clinical practices.
- Develop program strategies and oversee trials evaluating the safety, efficacy, medical usefulness, and value of drug or medical device candidates.
- Interpret and communicate Phase I-IV clinical investigation results for new drug preparation.
- Serve as signatory for NDA submissions and clinical study and safety documents.
- Provide strategic oversight of vendor and CRO relationships, including clinical input into governance committees.
- Lead and support regulatory filing activities by shaping clear, concise, and persuasive clinical communications.
Requirements
- MD or DO, preferably with genetics, metabolic medicine, rare disease, or immunology expertise; other clinical or scientific doctorates may be considered with clinician support.
- At least 5 years of clinical research or drug development experience across Phase I-IV activities.
- Typically 3–6 years of relevant experience for Director-level entry, depending on the type of experience.
- Advanced knowledge of drug development, clinical trial implementation, management, and reporting.
- Experience leading, managing, and motivating internal staff, investigators, or consultants.
- Knowledge of global regulatory requirements and related disciplines including immunology, biostatistics, clinical pharmacology, data management, and medical writing.
Nice to have
- Supplementary PhD, MPH, or MBA degree.
- Prior personnel management experience.
- Successful regulatory filing experience.
Culture & Benefits
- Medical, dental, vision, and prescription drug coverage.
- Company-provided life, accidental death and dismemberment, and short- and long-term disability insurance.
- Tuition reimbursement and student loan assistance.
- Generous 401(k) match, flexible time off, paid holidays, and paid leave programs.
- Collaboration is guided by accountability, strategic thinking, patient and customer centricity, respectful collaboration, and professional development.
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